A Controlled Trial of High Dietary Fiber Intake on Serum Lipids

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00593632

Enrollment

Registered

2008-01-15

Start date

2008-01-31

Completion date

2013-07-31

Last updated

2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

low HDL

Brief summary

The study evaluates high fiber diet intake in patients with hyperlipidemia.

Detailed description

Dietary fiber intake has been shown to have modest effect in lowering cholesterol. However, most of these studies were done with 20g/daily fiber intake. Not much is known about high dietary fiber intake (30-40 g/day) and serum cholesterol. Also, there have been small studies that have shown modest decrease in oxidative stress by increasing dietary fiber intake. The goal of our study is to determine the efficacy /safety of high dietary fiber intake in raising HDL, lowering LDL, and lowering oxidative stress in patients with hyperlipidemia.

Interventions

DIETARY_SUPPLEMENTUncle Sam Cereal

two 3/4 cup servings daily of Uncle Sam Cereal dietary instruction on high fiber diet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* All primary and secondary prevention patients aged 18 to 80 years with known or newly diagnosed isolated hypercholesteremia or combined hyperlipidemia. * Inclusion criteria include patients with HDL \< 35 mg/dL for a man or \< 45mg/dL for women irrespective of LDL level.

Exclusion criteria

* Any patients with unstable angina, untreated hypothyroidism, uncontrolled diabetes, other endocrine or metabolic diseases not actively treated, acute inflammatory diseases, severe gastrointestinal diseases, chronic renal insufficiency (GFR\<30), end stage renal disease, liver disease or other severe diseases such as cancer, triglyceride level greater than 600 mg/dL, pregnant females, chronic use of systemic corticosteroid, or anticoagulants. * Patients who were recently started or recently had their lipid lowering medications changed within the last 4 weeks will be excluded.

Design outcomes

Primary

Measure	Time frame
To test whether 30-40g of daily dietary fiber increases HDL, lowers total cholesterol and LDL levels in patients at 12 weeks	12 weeks

Secondary

Measure	Time frame
To test whether Lipoprotein (a), triglyceride level, LDL: HDL ratio, fibrinogen, CRP, Urine f1 2 isoprostane and body weight will be lowered in patients after 12weeks.	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026